Efficacy of NICE Classification in the Histological Evaluation of Colorectal Lesions
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|ClinicalTrials.gov Identifier: NCT02033980|
Recruitment Status : Unknown
Verified May 2016 by Zhizheng Ge, Shanghai Jiao Tong University School of Medicine.
Recruitment status was: Recruiting
First Posted : January 13, 2014
Last Update Posted : May 10, 2016
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Polyps||Device: NBI||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy of NICE Classification in the Histological Evaluation of Colorectal Lesions ----- a Multicenter Study in China|
|Study Start Date :||May 2016|
|Estimated Primary Completion Date :||June 2017|
|Estimated Study Completion Date :||August 2017|
All lesions will be observed with NBI and removed endoscopically or surgically for histological diagnosis.
All detected colorectal lesions will be examined by high-definition NBI. For type 2 and type 3 lesions, subsequent magnifying NBI examination will be performed.
- Accuracy of NICE classification in histological prediction by gastroenterological fellows [ Time Frame: within two weeks after polypectomy ]Diagnostic accuracy of gastroenterological fellows using non-magnified NBI according to NICE classification in histological prediction of polyps, compared with histologic examination
- Diagnostic accuracy of high-definition and magnifying NBI for type 2 and type 3 lesions. [ Time Frame: two weeks after endoscopical or surgical resection ]For lesions identified as type 2 or type 3, subsequent magnifying NBI examination will be performed by NBI experts. Before that, experts will make their own assessment according to all the images taken by gastroenterological fellows, blind to their diagnosis. Then experts will examine the lesions using magnifying endoscopy with NBI capability and make a new assessment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02033980
|Contact: Zhizheng Ge, MD,Ph.Demail@example.com|
|Ren Ji Hospital, School of Medicine, Shanghai Jiaotong University||Recruiting|
|Shanghai, China, 200001|
|Principal Investigator: Zhizheng Ge, MD, Ph.D|
|Principal Investigator:||Zhizheng Ge, MD,Ph.D||Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai ,China.|